docetaxel in treating older women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

objectives: primary * determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by lawton's instrumental activities of daily living scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel. secondary * determine the response rate in patients treated with this drug. * determine overall and progression-free survival of patients treated with this drug. * determine the degree of autonomy in daily activities as measured by katz's activities of daily living scale, in patients treated with this drug. * determine mood status, as measured by the geriatric depression scale, of patients treated with this drug. * determine toxicity of this drug in these patients. outline: this is a multicenter study. patients receive docetaxel iv on days 1 and 15. treatment repeats every 28 days for 6 courses. ability to perform daily activities is assessed periodically. projected accrual: a total of 53 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the breast * metastatic disease * measurable disease by ct scan or mri * requires first-line chemotherapy for metastatic disease * hormone receptor status: * not specified patient characteristics: age * 70 and over sex * female menopausal status * not specified performance status * meets both of the following criteria: * lawton's instrumental activities of daily living score ≥ 4 * katz's activities of daily living score ≥ 4 life expectancy * more than 3 months hematopoietic * hemoglobin \> 10 g/dl * neutrophil count \> 1,500/mm\^3 * platelet count \> 100,000/mm\^3 hepatic * alt and ast \< 1.5 times normal * bilirubin normal * alkaline phosphatase \< 2.5 times normal renal * creatinine clearance \> 30 ml/min cardiovascular * no congestive heart failure * no unstable angina pectoris * no myocardial infarction within the past year * no uncontrolled hypertension * no high-risk uncontrolled arrhythmias other * geriatric depression score \< 12 * no active uncontrolled infection * no active peptic ulcer * no uncontrolled diabetes mellitus * no inflammatory bowel disease * no history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80 * no history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent * no familial, social, geographical, or psychological condition that would preclude study follow-up * no definite contraindication to corticosteroids * no other serious illness or medical condition * no other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy * no prior or concurrent trastuzumab (herceptin\^®) chemotherapy * prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed * more than 2 years since prior docetaxel or paclitaxel * no other concurrent chemotherapy endocrine therapy * no more than 1 prior hormonal therapy regimen for metastatic disease * at least 10 days since prior hormonal therapy * no concurrent hormonal therapy * no concurrent chronic corticosteroids * concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated \> 6 months before study entry radiotherapy * not specified surgery * not specified other * more than 30 days since prior active treatment on another clinical trial * concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia * no other concurrent anticancer therapy * no other concurrent investigational drugs

Keywords: stage iv breast cancer recurrent breast cancer